The U.S. Food and Drug Administration (FDA) has approved Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC), an autoimmune disease affecting the bile ducts. The approval is contingent on verifying clinical benefits in confirmatory trials.
In a Phase 3 study, Livdelzi achieved a significant composite biochemical response in 62% of participants compared to 20% receiving a placebo. It led to the normalization of alkaline phosphatase (ALP) levels, a predictor of transplant risk and death, in 25% of participants. This was not seen in the placebo group.
Livdelzi also showed a statistically significant reduction in pruritus (itching) compared to placebo. However, improved survival or prevention of liver damage has not been demonstrated.
PBC is a chronic disease that affects primarily women. It can cause liver damage and failure if untreated. Livdelzi, an oral medication, targets the peroxisome proliferator-activated receptor (PPAR) delta. It challenges existing treatment options that often prove inadequate, leaving patients at risk of further liver damage.
Livdelzi has demonstrated sustained efficacy and safety in clinical trials. The normalization of ALP levels, a key indicator of disease progression, is now considered a treatment goal by healthcare providers.
The approval of Livdelzi marks a significant advancement for PBC patients with long-awaited new therapies. Its distinct profile provides a vital treatment option for managing the debilitating symptoms and disease progression associated with PBC.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
